Perioperative Intravenous Administration of High Volume Lactated Ringers Solution and the Risk of post-ERCP Pancreatitis
Aims: Pancreatitis (inflammation of the pancreas) is the most frequent serious complication of endoscopic retrograde cholangiopancreatography (ERCP) resulting in prolonged hospitalizations and in rare cases, death. ERCP is a procedure where  a long tube is inserted down the esophagus, through the stomach, and into the duodenum (small intestine). ERCP procedures are typically used to treat problems of the pancreas or bile ducts that can cause abdominal pain and elevated enzymes. The purpose of the study is to examine whether giving large amounts (2 – 3 liters) of intravenous (IV) fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis (PEP). Typically, a small amount of IV fluids are given during this procedure (approximately 1 liter). It is believed that the administration of increased fluids will allow circulation within the pancreas to continue during the procedure, thus decreasing the risk of injury and subsequent inflammation. 
Diagnosis:
Pancreatitis
Principal Investigator:
Mick S. Meiselman, MD
IRB Approval Number:
EH 13-130
Sponsor:
 NorthShore University HealthSystem
Contact:
 Interested patients should contact study coordinator Asantewaa Ture at 847.570.3708
Open to Enrollment:
Yes

The role of genotypic clarithromycin resistance testing using PCR detection of 23S mutations in predicting failure of eradication of Helicobacter pylori infection with standardized clarithromycin proton pump inhibitor (PPI) based triple therapy
Aims: Helicobacter pylori (H. pylori) is a bacterium that infects the stomach and can cause peptic ulcers and stomach cancer.  Normally, H. pylori is tested for using a CLO test, a urease breath test, a stool antigen test, or tissue biopsy. In addition, the treatment for the bacteria typically consists of clarithromycin triple therapy. There is data that suggests the clarithromycin triple therapy may not cure H. pylori infections in up to 30% of cases in the United States. Therefore, the purpose of this study is to determine whether molecular tests done on H. pylori bacteria taken from stomach tissue can predict clarithromycin treatment failure. H. pylori can have genes that make it resistant to specific drugs. By testing stomach tissues (taken during an esophagogastroduodenoscopy or EGD), we will be able to determine whether H. pylori will respond to certain types of drugs. 
Diagnosis:
H. pylori Infection
Principal Investigator:
Karen Kaul, MD, PhD
Other Investigator: Jay Goldstein, MD and Dena Shibib, DO
IRB Approval Number:
EH 13-101
Sponsor:
 NorthShore University HealthSystem Department of Medicine and Department of Pathology
Contact:
 Interested patients should contact Boris Jancan, CCRP at 847.570.1583
Open to Enrollment:
Yes

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
Aims: Celiac disease is an inherited, life-long disease affecting children and adults. There is no drug treatment or cure for celiac disease. When people with celiac disease eat gluten (a plant protein found in foods like wheat, rye, barley, and many everyday products), there is a reaction that damages their small intestine and interferes with the ability of their intestine to take in nutrients.  ALV003 is an investigational drug under development by Alvine Pharmaceuticals that can break down gluten into smaller pieces of protein. The smaller protein fragments are expected to be less damaging to the small intestine. The purpose of the study is to determine whether ALV003 is able to improve the damage in the lining of the intestine caused by gluten. In addition, the study will determine whether ALV0003 improves any of the symptoms related to celiac disease.    
Diagnosis:
Celiac Disease
Principal Investigator:
Jay Goldstein, MD
Other Investigators: David Labowitz, DO and Eugene Yen, MD
IRB Approval Number:
EH13-212
Sponsor:
 Alvine Pharmaceuticals, Incorporated
Contact:
 This study is closed to enrollment.
Open to Enrollment:
 No

A Randomized, 12-week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patient with Chronic Idiopathic Constipation
Aims: This study will evaluate the efficacy and safety of 3.0 mg and 6.0 mg plecanatide versus placebo in patients with chronic idiopathic constipation. Participants will be given rescue medication (Ducolax), but will have restrictions on how often the rescue medication can be used. Plecanatide causes increased fluid secretion within the colon. The fluid secretion is expected to facilitate bowel movements.
Diagnosis: Chronic Idiopathic Constipation
Principal Investigator
: Jay Goldstein, MD
Other Investigators:
Eugene Yen, MD, Laura Bianchi, MD, and David Labowitz, DO
IRB Approval Number: EH 14-041
Sponsor: Synergy Pharmaceuticals
Contact: This study is closed to enrollment.
Open to Enrollment: No

Fecal Microbiota Transplantation (FMT) / Stool Transplant
Aims: C. difficile is not only occurring more frequently, but there is also an epidemic of serious cases which are refractory to therapy and have high rates of colectomy and death. The use of antimicrobials may predispose patients to further relapses by disturbing intestinal flora and can contribute to the problem of drug resistance. FMT has been shown to restore phylogenetic richness and diversity of the intestinal microbiome thereby restoring colonization resistance. Dr. Yen and several Infectious Disease physicians oversee screening and scheduling patients who may qualify to receive a stool transplant.
Diagnosis: C. difficile infection 
Principal Investigator
: Eugene Yen, MD
Other Investigators:
Becky Smith, MD, Leonard Kaplan, MD, Stephen Schrantz, MD, Jeffery Semel, MD, Shailesh Bajaj, MD, David Labowitz, DO, and Todd Nega, MD
IRB Approval Number: EH 13-450
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contactstudy coordinator Asantewaa Ture at 847.570.3708
Open to Enrollment:
Yes

Fecal Microbiota Transplant (FMT) versus Standard Medical Therapy for Initial Treatment of Recurrent Clostridium difficile Infection
Aims: C. difficile is not only occurring more frequently, but there is also an epidemic of serious cases, which are refractory to therapy and have high rates of colectomy and death.  The use of antimicrobials may predispose patients to further relapses by disturbing intestinal flora and can contribute to the problem of drug resistance.  FMT has been shown to restore phylogenetic richness and diversity of the intestinal microbiome thereby restoring colonization resistance.  Our previous FMT research study has proven highly effective for the patient population infected with recurrent or refractory CDI.  Dr. Smith believes that administration of FMT at an earlier time point (first recurrence) will led to reduced relapses and reduced morbidity associated with those relapses in comparison to standard antibiotic therapy.  The primary outcome will be clinical resolution of diarrhea without recurrence of CDI within 90 days.
Diagnosis:  C. difficile infection 
Principal Investigator:  Becky Smith, MD
Other Investigators: Eugene Yen, MD, Nicole Gentile, MD, and Edward Schaefer, MD
IRB Approval Number:  EH 14-331
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact study coordinator Asantewaa Ture at 847.570.3708
Open to Enrollment:  Yes

Efficacy, Immunogenicity, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection
Aims: Clostridium difficile (C. diff) is a potentially deadly bacterium emerging as the leading cause of life-threatening, healthcare-associated infections worldwide. Symptoms range from mild diarrhea to life-threatening colitis. The purpose of this study is to evaluate the efficacy of a C. difficile vaccine in preventing the onset of this diarrheal disease in adult subjects ≥ 50 years who are at risk for acquiring it. Patients may be eligible to participate in this study if they are at least 50 years of age and meet one of the following risk strata:

  1. Have had at least 2 hospital stays, each lasting ≥ 24 hours, in the last 12 months AND have received systemic antibiotics sometime in the last 12 months.
  2. Have a planned surgical procedure with an impending hospital stay of ≥ 72 hours

Patients who currently have or have had C. difficile infection are unable to participate.
Diagnosis: None
Principal Investigator: Stephen Schrantz, MD
Other Investigators: Jeffery Semel, MD and Jay Goldstein, MD
IRB Approval Number: EH14-085
Sponsor: Sanofi Pasteur
Contact: Interested patients should contact study coordinator Colleen Leonardat 847.570.3558
Open to Enrollment: Yes

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